NCT04228211|RecruitingDMC
Utrecht Prostate Cohort for Cancer Treatment Intervention Studies and Long-term Evaluation
UPC
Loading search results
UPC
Sponsor study identifier
observational
1,500
1 country
2
Study Start
February 5, 2020
Actual (reported)Primary Completion
February 5, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 5, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Rationale: Prostate cancer is the most common cancer in men worldwide. Survival rates are high due to the typically non-aggressive nature of disease and effective treatments. Radical treatments such as surgery and radiotherapy often cause toxicity and long term side effects. Based on current available literature, the choice for primary therapy for clinically localised prostate cancer has a negative impact on cancer-specific quality of life (QOL). New interventional treatments are being developed. The investigators aim to build a multidisciplinary prostate cancer cohort which will serve as a multi-trial facility for interventional treatment studies. The Trials within Cohorts (TwiCs) design, also known as cohort multiple Randomized Controlled Trial design (cmRCT) will be conducted and as a prospective registry for assessment of long-term safety, performance and effectiveness new treatment interventions. Objective: To set up a cohort that will serve as a multi-trial platform and facilitate evaluation of new interventional treatment for prostate cancer. Study design: Observational, prospective cohort study, according to the 'Trials within Cohorts' (TwiCs) design. Study population: All patients with newly diagnosed histologically proven prostate cancer. Main study parameters/endpoints: Clinical parameters (e.g. co-morbidity, oncological history, symptoms, imaging, technical and treatment data), clinical endpoints (e.g. toxicity, and survival outcomes) and patient reported outcomes (e.g. QOL).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 5, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 3, 2020
Actual (reported)January 14, 2020
Actual (reported)February 5, 2020
Actual (reported)February 5, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 5, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change from baseline Quality of Life
Assesment of Health-related quality of life in prostate cancer patients undergoing treatment
Up to 10 years after treatment
Occurence of toxicity (adverse events)
All toxicity occurring during or after treatment will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 5) and Clavien Dindo classification, for radiotherapy and surgery respectively.
Up to 10 years after treatment
Occurence of disease recurrence/progression
Biochemical prostate specifice antigen (PSA) recurrence/progression and recurrence/progression based on medical imaging
Up to 10 years after treatment
Survival
Up to 10 years after treatment
All patients with newly diagnosed histologically proven prostate cancer, referred for radiation treatment to the Radiotherapy Department of the UMC Utrecht or for prostatectomy, watchful waiting or active surveillance to the Urology Department of St. Antonius hospital or the Urology Department of the UMC Utrecht will be eligible to be enrolled in the cohort.
St. Antonius Hospital
Nieuwegein, Utrecht, 3435CM, Netherlands
University Medical Center Utrecht
Utrecht, Utrecht, 3508GA, Netherlands
Teunissen FR, Willigenburg T, Meijer RP, van Melick HHE, Verkooijen HM, van der Voort van Zyp JRN. The first patient-reported outcomes from the Utrecht Prostate Cohort (UPC): the first platform facilitating 'trials within cohorts' (TwiCs) for the evaluation of interventions for prostate cancer. World J Urol. 2022 Sep;40(9):2205-2212. doi: 10.1007/s00345-022-04092-2. Epub 2022 Jul 21.
Helena M. Verkooijen, MD, PhD
UMC Utrecht
Jochem R.N. van der Voort van Zyp, MD, PhD
UMC Utrecht
Harm H.E. van Melick, MD, PhD
St. Antonius Hospital
First Submitted
January 3, 2020
First Posted
January 14, 2020
Study Start
February 5, 2020
Actual (reported)Primary Completion
February 5, 2030
EstimatedComparison of PET Imaging Patterns With PSMA and AR Expression in Prostate Cancer and Bladder Cancer
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 5, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 5, 2026
Record last verified: 2026-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: